Phase 4
N=124
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00452335 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
Aug 2016
Primary outcome: Primary: Frequency of Spontaneous Bowel Movements — 2.47; 3.02; 3.84 spontaneous bowel movements per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lubiprostone (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Spontaneous Bowel Movements |
2.79; 2.59; 3.51; 2.64; 2.60; 3.58 | — |
| SECONDARY Frequency of Spontaneous Bowel Movements |
2.79; 2.59; 3.51; 2.64; 2.60; 3.58 | — |
| SECONDARY Frequency of Fecal Incontinence |
0.53; 0.22; 0.03; 0.37; 0.21; 0.05 | — |
| SECONDARY Straining Associated With SBMs |
1.70; 1.34; 1.44; 1.02; 1.22; 1.30 | — |
| SECONDARY Stool Consistency of SBMs |
2.87; 3.20; 3.14; 3.09; 2.90; 3.22 | — |
| SECONDARY Abdominal Bloating |
1.16; 1.39; 1.79; 1.08; 1.12; 1.16 | — |
| SECONDARY Abdominal Discomfort |
0.84; 1.16; 1.43; 1.08; 0.93; 1.20 | — |
| SECONDARY Pain Associated With SBMs |
1.56; 1.13; 1.14; 0.72; 1.06; 1.10 | — |
| SECONDARY Constipation Severity |
1.92; 1.69; 1.79; 1.46; 1.43; 1.40 | — |
| SECONDARY Treatment Effectiveness |
1.2; 1.6; 1.7; 1.6; 1.7; 2.0 | — |
Summary
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
Eligibility Criteria
Inclusion Criteria
- Less than 18 years of age
- Weight of at least 12 kg and capable of swallowing a capsule
- Able to refrain from use of medications known to treat or associated with constipation symptoms
- Stable fiber therapy or ADHD therapy if using such medications
- Patient/Caregiver able to complete daily diary
- Patient able to use recommended rectal and/or oral rescue medications if needed
Exclusion Criteria
- Constipation is associated with some medical, anatomic, physical, organic, or other condition
- Hirschsprung's Disease or Nonretentive Fecal Incontinence
- Untreated fecal impactions or impactions requiring digital manipulation
- Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
- Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
- Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
- If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
- Sexually active males and females must utilize acceptable birth control methods
- Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Data sourced from ClinicalTrials.gov (NCT00452335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.